koyaaniskatsi (from the hopi language) n. 1. crazy life. 2. life in turmoil. 3. life disintegrating. 4. life out of balance. 5. a state of life that calls for another way of living.
From the dust jacket of the Philip Glass album Koyaaniskatsi

September 4 2003 - Something is terribly wrong with the way some criminal justice authorities have begun to enforce the law against physicians and pharmacists who prescribe and dispense high dose opioids to treat chronic pain. The necessary balance in pain policy described by David Joranson and June Dahl of the University of Wisconsin has tipped drastically in the direction of ruthless drug control and away from compassionate collaboration. This is a recent development. The past five years has generated an unprecedented list of health care providers charged with murder for allegedly providing inappropriately large quantities of opioids to pain patients.

In Kansas, Dr. Stan Naramore was convicted of murdering one patient and attempting the murder of another, but his conviction was overturned on appeal. Murder charges were filed against Indiana physician Jong Bek, and later dropped for lack of evidence. Dr. Robert Weitzel of Salt Lake City was charged with first-degree murder and convicted of manslaughter and negligent homicide, then acquitted on retrial. In California, five charges of first-degree murder were brought against Dr. Frank Fisher, Pharmacist Stephen Miller, and Miller's wife Madeline Miller, but were dismissed four years later due to lack of evidence. These are the happy-ending stories.

Dr. James Graves of Pace, Florida, charged with murder and convicted of manslaughter, now waits in prison for his appeal to be heard. Murder charges have been filed against Florida physician Denis Deonarine, Dr. Spurgeon Green from Georgia, and Dr. Jesse Benjamin Henry from Albuquerque (as well as Hong Lu Henry, Dr. Henry's wife). Other physicians and pharmacists have been charged with lesser crimes resulting from their prescribing or dispensing of opioid analgesics.

This is drug control policy out of balance. It creates a "chilling effect" on the prescribing and dispensing of opioids for legitimate pain patients. It is a state of regulation that calls for a different way of regulating.

Balance is an appealing concept in everyday life. Most people try to balance work with family, personal concerns with social concerns, and present needs with future needs. Achieving balance is a familiar activity.

Scientists try to balance the likelihood of two errors. Type I error occurs when a hypothesis is considered proven, but in fact it is false. Type II error occurs when a hypothesis is considered unproven, but in fact it is true. The more one attempts to reduce the probability of Type I error, the more one increases the probability of Type II error, and vice-versa. The sum of the two errors is minimized when they are balanced, not when the avoidance of one is emphasized over avoidance of the other.

The result is similar in law enforcement, because it is impossible to know in advance whether high dose opioid prescriptions have been issued or dispensed for a legitimate medical purpose. There is no laboratory value or diagnostic image that can confirm pain. The threat of strong law enforcement can prevent many drug diverters from accessing medications, but many legitimate patients will also be denied. Behaviors designed to reduce the error of providing controlled substances to drug diverters will increase the error of refusing controlled substances to legitimate pain patients.

It is interesting to note that the "red flags" used by regulators to identify inappropriate controlled substance prescribing and dispensing, are in many ways similar or identical to the criteria health care providers use in identifying appropriate pain management practice. The difference perception of these factors can lead to imbalance.

Consider the ambiguity of these red flags:

• Patient comes from a long distance.
  Regulators become concerned when patients travel many hundreds of miles to a receive prescriptions for opioids. They wonder why patients don't just get their medications in their own community. But as the specialty of pain management emerges, and as primary care practitioners are encouraged to refer pain patients to specialists, it becomes increasingly more common to refer pain patients to physicians who may be a considerable distance from the patient's home.

• Large quantity of controlled substances prescribed.
  The prescribing of large quantities of opioids will attract regulatory attention to any physician, and it probably should. Regulators may claim to be unaffected by high volume, but that is not the reality of the current regulatory climate. In health care, however, a high volume of opioids for pain patients is a badge of honor among those who truly do what is right to meet the needs of those who suffer.

• The dose is potentially lethal.
  Regulators may become concerned with large doses that would kill an opiate naive patient. Yet, health care providers recognize that analgesic tolerance may require increasing doses to as high a level as is needed to achieve analgesia without intolerable side effects. Drugs don't have doses, patients have doses.

• The patient asked for drugs by name.
  To a regulator, it will seem suspicious that a pain patient refuses medications that are not controlled substances and insists that only specific opiates will work. This is the sign of a "drug seeker." A health care provider will appreciateknowing what drugs a documented pain patient has found, through experience, to be safe and effective for that patient. There is no need to again try those drugs that have not worked in the past.

• The doctor prescribes whatever the patients want.
  To a regulator it will seem suspicious that a physician will prescribe based on the patient's expressed needs rather on objective clinical findings. But health care providers are moving in the direction of learning the patient's functional goals and trying to meet those goals. A successful health care practice focuses on the patients' quality of life, not on objective clinical findings.

• Patients return too early.
  It is alarming to regulators that a patient who has received a thirty-day of supply of medication may run out of medication early and return before thirty days, without an appointment, to receive additional medication. Health care providers know that a health crisis cannot be scheduled, and that patients whose condition suddenly worsens must be seen immediately. A gap in treatment may send the patient into a downward spiral or may force the patient to use non-medical street drugs to obtain relief.

• The patient is directed to use multiple pharmacies.
  For a regulator, the fact that a patient has been told to go to several different pharmacies may be seen as suspicious, and it should be. On the other hand, in a community where pharmacists are frightened by law enforcement and are reluctant to dispense large quantities of opioids, the only choice may be to use several pharmacies to obtain the required amount of medication.

• Many different drugs are being prescribed.
  The prescribing and dispensing of many different controlled substances for seemingly unrelated conditions will signify to regulators the possibility of drug diversion rather than legitimate medical care. In pain management, however, health care providers realize that anxiety, insomnia, and depression are accompanying conditions that require additional pharmacological treatment to meet the patients' needs.

All of these red flags have alternative meanings, based on the perspective of either a drug control regulator or a pain management professional. To a drug control regulator they are signs that something is going wrong. To a health care provider they are signs that things are going right. Discerning the reality of whatever these red flags suggest requires drug control regulators and health care providers to go beyond mere "indicators" and talk openly with each other. Unfortunately, the culture of law enforcement does not lend itself well to open dialogue. Law enforcement is trained to conduct discreet surveillance, gather evidence, and then use massive force when the time is right. Early dialogue looks to them too much like teaching criminals how to not get caught. Health care providers are also skittish about early dialogue. A legacy of suspicion and distrust makes them reluctant to draw attention to themselves and perhaps implicate themselves in wrong doing by contacting law enforcement.

A system must be developed to facilitate early dialogue so that ambiguous red flags are clarified. This system would include consults between law enforcement officers and specific health care providers who are under suspicion, as well as consults with expert peer reviewers with knowledge of practice standards. The following flow chart describes one such possible system. I would welcome comments about the flow chart from anyone.

David Brushwood is Professor of Pharmacy Health Care Administration at the University of Florida in Gainesville. He is a Mayday Scholar with the American Society of Law, Medicine and Ethics (ASLME).
For information about ASLME pain policy projects, go to ASLME.